miércoles, 9 de enero de 2013

FDA releases two long-awaited Food Safety Rules

The public will have 120 days to comment the
two rules mandated by the FSMA

After a year-long delay, two sweeping new
food safety rules that will for the first time mandate produce safety standards
and preventive controls nationwide will be released today and published to the
Federal Register on Monday, according to the U.S. Food and Drug Administration.

“It’s a big deal that these two are coming
out because it’s the central framework for prevention,” said Michael Taylor,
FDA’s Deputy Commissioner for Foods and Veterinary Medicine, in an interview
with Food Safety News. “We’re eager to get to the next phase of the process.”

The two rules were mandated by the Food
Safety Modernization Act (FSMA) — a law that aims to shift the U.S. food safety
system from being primarily reactive to focusing on prevention — which
President Obama signed into law, with broad bipartisan support, exactly two
years ago.

Since the law was enacted, the FDA has
failed to keep up with the multiple deadlines set by Congress, in large part
because the measures proposed by the agency were under review at the White
House Office of Management and Budget’s Office of International and Regulatory
Affairs for more than a year — a delay many stakeholders blamed on election
politics.

It is still not clear exactly why the Obama
administration’s review took so long (OMB officials have long maintained the
rules are just complex and take time). According to Taylor, the OMB’s
cost-benefit analysis, which will soon be posted online, found that the
economic benefits from the two new rules are much greater than the expected costs
to the food industry.

“There are significant benefits that well
exceed the estimated costs,” said Taylor, adding that preventing outbreaks and
the health care costs associated with them is actually one small part of the
expected economic benefit. “There’s a great benefit in reducing the disruption
to the markets, the loss of sales, and the loss of consumer confidence each
time a major foodborne illness outbreak strikes.”

The agency has made full drafts of the
proposed rules, which are lengthy, available online. The public will have 120
days to comment and then the rule will go through the normal rulemaking
process, which could take several months.

It will likely take time for stakeholders
to review the proposed rules, as the agency has not yet released an overview of
what exactly would be required under the proposal, but the early reactions were
unanimously positive.

One of the key elements of the proposed
rule for produce focuses on water. If a farm is applying water to the edible
part of the crop, it will likely have to meet a microbial standard, or explain
why such a standard isn’t relevant to that specific product.